COVID-19
Conditions
Brief summary
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of APR002 in healthy subjects.
Detailed description
A Phase 1, Randomized, Blinded, Placebo-Controlled, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APR002 Administered by Inhalation in Healthy Volunteers
Interventions
DRUGAPR002
Active Investigational Product
DRUGPlacebo
Placebo
Sponsors
CMAX Clinical Research Pty Limited
Avance Clinical Pty Ltd.
Global Health Drug Discovery Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men or women aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. * Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method * Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months * Have a body mass index (BMI) between 18 and 32 kg/m2 and weigh at least 45 kg.
Exclusion criteria
* History or presence of clinically significant medical (e.g., chronic obstructive pulmonary disease, asthma, COVID-19, etc.) or psychiatric condition or disease * Abnormal vital signs, after minutes rest, defined as any of the following (SBP \> 140 mmHg, Diastolic blood pressure (DBP) \> 90 mmHg, Heart rate \< 40 or \> 99 beats per minute) * Prolonged QTcF \> 450 ms or family history of long QT syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of APR002 in healthy subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria | Screening up to Day 14 | Safety assessments will include evaluation of incidence of treatment-emergent adverse events (AEs) according to CTCAE v5.0 criteria, including vital signs, resting electrocardiogram (ECG) parameters, standard hematology, chemistry, urinalysis and other tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of APR002 in healthy subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose | Day 1 to Day 3 | Determination of maximum plasma concentration (Cmax) |
| Pharmacokinetics of APR002 in healthy subjects as assessed by time to maximum concentration (Tmax) towards determination of the optimal pharmacokinetic dose | Day 1 to Day 3 | Determination of time to maximum concentration |
| Pharmacokinetics of APR002 in healthy subjects as assessed by plasma exposure (AUC0-t, AUC0-inf) determination of the optimal pharmacokinetic dose | Day 1 to Day 3 | Determination of plasma exposure (AUC0-t, AUC0-inf) |
| Pharmacokinetics of APR002 in healthy subjects as assessed by terminal elimination half life (t1/2) determination of the optimal pharmacokinetic dose | Day 1 to Day 3 | Determination of terminal half life |
| Pharmacokinetics of APR002 in healthy subjects as assessed by apparent volume of distribution during the terminal elimination phase after inhalation (extravascular) administration for determination of the optimal pharmacokinetic dose | Day 1 to Day 3 | Determination of volume of distribution (CL/F and Vz/F) |
Countries
Australia
Outcome results
None listed